pulmicort and Conjunctivitis

The clinical potency of budesonide, a new glucocorticosteroid, was compared in a randomized double-blind study with beclomethasone dipropionate in the treatment of seasonal allergic rhinitis during the ragweed-pollen season. Sixty-one subjects were matched according to their skin sensitivity to ragweed-pollen extract and the severity of ragweed-induced rhinitis during the previous season. Thirty subjects received budesonide, and 31 received beclomethasone dipropionate, 50 micrograms per actuation. A double-dummy technique was used to achieve blinding, since the aerosol canisters and adaptors were dissimilar. Subjects were instructed to keep rhinitis well controlled by starting intranasal trial medication as soon as symptoms became troublesome, two puffs into each nostril, when it was needed, up to four times per day. If this became inadequate, subjects received supplementary chlorpheniramine maleate, 4 mg. Nasal symptoms (none = 0, mild = 1, moderate = 2, and severe = 3) and all medication use were recorded daily in a diary. Budesonide demonstrated better clinical potency than beclomethasone in that less was needed to maintain good control of nasal symptoms. Side effects were mild and transient for both groups.

Topics: Administration, Inhalation; Beclomethasone; Budesonide; Conjunctivitis; Cough; Female; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal

Quality of life (QOL) issues resulting from participation in an allergy research trial, or indeed any clinical trial, is not documented in the medical literature.. To determine whether participating in a trial where allergic symptoms are induced has a significant impact on subjects' QOL, and to quantify extent and duration.. Subjects were recruited from a trial utilizing a controlled allergen environment to assess anti-allergic medications. A QOL survey (consisting of the Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ] & the SF-36) was completed at screening, on study day, and approximately 2 weeks post-study. Follow-up was sought from subjects' whose QOL was significantly worse than baseline.. Of 219 trial participants, 206 completed both screening and study surveys; 141 returned at least one follow-up survey; and 136 constructed the final dataset. Mean overall scores at follow-up via RQLQ were significantly better than screening (P < .001). Significant decreases in QOL from baseline on study day occurred in social function on the SF-36 (P = .026) and in domains of sleep (P = .019), non-nasal symptoms (P = .05), ocular symptoms (P < .001), and nasal symptoms (P < .001) on the RQLQ. Average post-study follow-up was 17.1 days (range = 5 to 55 days).. Subjects participating in a trial involving allergic symptom induction experienced a decrease of QOL in parameters specific to rhinoconjunctivitis and social function. Subjects' QOL returned to or improved over baseline within 2 1/2 weeks. Positive QOL findings are important to studies where symptoms are induced and also have relevance to standard Phase 3 drug trials.

Topics: Allergens; Anti-Allergic Agents; Bronchodilator Agents; Budesonide; Clinical Trials as Topic; Conjunctivitis; Follow-Up Studies; Histamine H1 Antagonists; Humans; Quality of Life; Rhinitis, Allergic, Seasonal; Surveys and Questionnaires